FDA.reportPublic FDA data

Bacitracin

Product NDC
59898-720
11-digit product format
598980720
Labeler code
59898
Product ID
59898-720_2b0a22f8-c57e-a927-e063-6294a90a459d
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Water-Jel Technologies
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-11-07
Substance
BACITRACIN ZINC
Active strength
500 [iU]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BacitracinBACITRACINWater-Jel Technologies412928a1-3708-4fa8-99c5-aaa2b079cf6e2025-01-06WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Do not use in the eyes or over large areas of the body if you are allergic to any of the ingredients longer than 1 week unless directed by a doctor Ask a doctor before use if you have a deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-720-01Bacitracin0.9 g in 1 PACKETOINTMENT0.910
59898-720-01Bacitracin1728 in 1 CARTONOINTMENT172810
59898-720-02Bacitracin144 in 1 BOX, UNIT-DOSEOINTMENT14410
59898-720-02Bacitracin0.9 g in 1 PACKETOINTMENT0.910
59898-720-03Bacitracin25 in 1 BOX, UNIT-DOSEOINTMENT2510
59898-720-03Bacitracin0.9 g in 1 PACKETOINTMENT0.910
59898-720-36Bacitracin0.9 g in 1 PACKETOINTMENT0.910

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESBACITRACIN (BACITRACIN) OINTMENT [WATER-JEL TECHNOLOGIES]7
BACITRACIN ZINCACTIVE MOIETY89Y4M234ESBACITRACIN (BACITRACIN) OINTMENT [WATER-JEL TECHNOLOGIES]7
PetrolatumINACTIVE INGREDIENT4T6H12BN9UBACITRACIN (BACITRACIN) OINTMENT [WATER-JEL TECHNOLOGIES]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-720BACITRACIN OINTMENT [WATER-JEL TECHNOLOGIES]10Current NDC, Legacy NDC, 7 package rows20250108_412928a1-3708-4fa8-99c5-aaa2b079cf6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN412928a1-3708-4fa8-99c5-aaa2b079cf6e10
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD412928a1-3708-4fa8-99c5-aaa2b079cf6e10
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY412928a1-3708-4fa8-99c5-aaa2b079cf6e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-720-01598980720011728 PACKET in 1 CARTON (59898-720-01) / .9 g in 1 PACKET1728 packet2010-11-070000-00-00NoNoCurrent
59898-720-0259898072002144 PACKET in 1 BOX, UNIT-DOSE (59898-720-02) / .9 g in 1 PACKET144 packet2010-11-070000-00-00NoNoCurrent
59898-720-035989807200325 PACKET in 1 BOX, UNIT-DOSE (59898-720-03) / .9 g in 1 PACKET25 packet2010-11-070000-00-00NoNoCurrent
59898-720-3659898072036.9 g in 1 PACKET (59898-720-36) 2010-11-070000-00-00NoNoCurrent